Erika Segear Johnson -- Guiding Investigators Through Regulatory Landscapes


October 23, 2015

Erika Segear Johnson started her PhD in molecular biology imagining she might be a professor at a small liberal arts college. Instead, she’s found her educational niche as a Regulatory Affairs Scientist in the CTSA Regulatory Affairs group. “Regulatory affairs is uncharted territory for most people,” she says. “Education is a big part of my job.”

Here, in her own words, is Segear Johnson’s account of how she discovered a passion for helping investigators navigate the complex territory governed by the U.S. Food and Drug Administration (FDA) in translational medicine.


Your job title is Regulatory Affairs Scientist. What does that entail?

I help investigators at Duke understand the regulatory requirements that apply to their research and assist them with meeting these requirements by facilitating interactions with the FDA and submitting and maintaining required regulatory documents. Since joining the CTSA Regulatory Affairs group in April 2014, I have focused on medical device work, so my days are quite varied. In any given week, I might be interacting with up to 10 different investigator teams. Sometimes I’m researching what similar devices are already exist on the market. Other times I’m writing up and compiling regulatory submissions, which describe the device, the design iterations that have been completed, the proposed safety testing, and much more. Often I am discussing with investigators the regulatory consequences of decisions they make as they move through the development process and bring their device to the market.


How did you end up in this career?

I did my PhD in Molecular Cancer Biology here at Duke and worked in the laboratory of Dr. Sally Kornbluth. I knew fairly early that I wasn’t cut out to spend my entire career as a bench scientist, so I explored different trajectories for graduate students as a part of the Duke Scholars in Molecular Medicine program. I knew some people who worked with the CTSA Regulatory Affairs team, and I participated in the CTSA Regulatory Affairs training program. That gave me a taste of what regulatory work might be like. I’ve also always had a love of education in my heart and thought I might be a professor at a small liberal arts college. When I got into this job I realized that even though I’m not teaching undergraduates, I’m still educating. Regulatory affairs is uncharted territory for most investigators, so people come to us and say “teach me, I want to learn.”


When did you know you wanted to be a scientist?

In 4th grade I had a fantastic science teacher who introduced us to laboratory-style experiments. We had a project over Thanksgiving to test members of our families to see if they could taste phenylthiocarbamide (PTC). There are underlying genetic markers which determine whether PTC “tastes” really bitter or appears virtually tasteless to a person. I tested everyone in my family – my parents and all five of my siblings. I turned out to be the only non-taster, and I couldn’t believe it. It got me really interested in experimental science.


Are you involved in the Regulatory Affairs Training programs?

Yes, everyone in Regulatory Affairs is involved in the onsite and remote training programs that our group offers. As part of the onsite program, we take turns presenting weekly lectures to program participants. For the remote program, we each run our own individual sessions which last approximately 6-8 weeks. I have been most involved in developing and running our online medical device training program. Since launching the program in January of this year, we’ve had 44 students go through this training.


What intrigues you about working with regulatory affairs around medical devices?

I like the variety. The FDA oversees devices that range from a toothbrush to an MRI machine –things that are very basic to devices that are incredibly complex. I’ve always liked to ask questions – it’s what scientists do – and in the world of medical devices, I get to ask lots of questions!


What is a memorable moment for you as a Regulatory Affairs Scientist at Duke?

One of the first projects I worked on by myself was the self-sealing vascular graft that was developed by Dr. Jeff Lawson, Dr. Roberto Manson, and Shawn Gage from vascular surgery. I prepared FDA submissions related to an in-person meeting we had with FDA in December of 2014. It was very exciting to guide the team along this path. It was intimidating at first, because I had never done it before, but it was a great feeling to see all of our work coming to fruition in that meeting.


What do you spend your time on when you are not at Duke?

My daughter, Porter, is two and a half years old so my husband, Timothy, and I spend a lot of time with her. In April of 2016, we’ll be adding another baby to the family, so that will keep us even busier! I am also very close to my family, who are all located in Pennsylvania. We were all recently together for my Dad’s 60th and my 30th birthday celebration. My family always pull me back to reality. To be with them or talk with them always reminds me that there is a lot more to life than just work.


Besides science and family, what else are you passionate about?

Growing up I was very passionate about competitive sports. I played soccer and volleyball, ran track and cross-country, and competed as a gymnast. That competitive time is done, but I still try to stay active. As a graduate student, I played on a recreational volleyball team, and I often think now about staying close to the sport by becoming a referee. I’m sure that when my children are old enough to be in sports, I’ll be a real sports mom!